UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042969 |
|---|---|
| Receipt number | R000049054 |
| Scientific Title | Study on the change of gastric emptying ability by vonoprazan |
| Date of disclosure of the study information | 2021/01/12 |
| Last modified on | 2021/06/23 20:22:05 |
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Basic information
Public title
Study on the change of gastric emptying ability by vonoprazan
Study on changes in gastric emptying ability due to suppression of acid secretion
Acronym
Study on the change of gastric emptying ability by vonoprazan
Scientific Title
Study on the change of gastric emptying ability by vonoprazan
Scientific Title:Acronym
Study on the change of gastric emptying ability by vonoprazan
Region
| Japan |
Condition
Condition
functional gastrointestinal disorder
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine how vonoprazan treatment alters gastric emptying capacity in healthy subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
gastric emptying breath test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
gastric emptying breath test
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Asymptomatic adults aged 20 to 75 years who participated in UMIN000039199.
Key exclusion criteria
Those who have symptoms of gastric acid reflux or gastric motility insufficiency. Patients with a history of gastrectomy. Patients with active malignancy. Patients with serious complications (heart failure, renal failure, liver failure, respiratory failure, intestinal obstruction) that make it difficult to perform the test. Patients with active gastric ulcer. Patients on dialysis. Pregnant or nursing mothers. Patients with swallowing dysfunction. Those who are allergic to bonoprazan. Patients who cannot express their own will due to dementia or impaired consciousness. Those who are unable to give their consent. Those who are judged as unsuitable as test subjects by the principal investigator (sub-investigator).
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kazuhide |
| Middle name | |
| Last name | Higuchi |
Organization
Osaka Medical College
Division name
Second Department of Internal Medicine
Zip code
569-8686
Address
2-7, Daigaku-machi, Takatsuki-City, Osaka
TEL
072-683-1221
higuchi@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Ota |
Organization
Osaka Medical College
Division name
Second department of internal medicine
Zip code
569-8686
Address
2-7, Daigaku-machi, Takatsuki-City, Osaka
TEL
072-683-1221
Homepage URL
in2112@osaka-med.ac.jp
Sponsor or person
Institute
Second Department of Internal Medicine, Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Second Department of Internal Medicine, Osaka Medical College
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical College
Address
2-7, Daigaku-Machi, Takatsuki-City, Osaka
Tel
072-683-1221
omc_rinsyou@osaka-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 11 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 24 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 24 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 11 | Day |
Last modified on
| 2021 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049054
